Document Control Specialist
2 weeks ago
SURGENEX is a privately held biotechnology company. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States.
POSITION SUMMARY
The Document Control Administrator (DCA) is responsible for maintaining and managing the document control system as part of the Quality Management System for Surgenex. This position shall submit, track and manage all documents through the system in a compliant, timely and effective manner. The DCA may also serves as an administrator for the electronic Quality Management System (QMS) platform.
KEY RESPONSIBILITIES
- Responsible for understanding the requirements of the paper / electronic document control system providing the required knowledge and skillset to administer the quality document control system for the organization.
- Receives and reviews document change orders (DCO).
- Responsible for ensuring all new and revised documents have the correct control number, template and properties set ensuring consistency of documents and compliance with internal procedures, spell check has been performed, and verify that all reviewer comments have been addressed and those applicable incorporated within the document.
- Track draft documents within the paper/electronic document control system to ensure all documents are being written, reviewed and approved in a timely manner; within the established timelines.
- Responsible for setting implementation dates within the paper/electronic document control system for new or revised documents ensuring sufficient time for staff training.
- Run necessary reports to ensure sufficient and applicable staff have read a new or revised document.
- Ensure effective processes are in place for the document read acknowledgment training.
- Archive documents per the established quality document control system standard operating procedure.
- Develop and execute on-going training for all Surgenex employees to ensure competent and efficient use of the document control paper / electronic system.Provide ongoing support to address all questions regarding the system.
- Conduct the final assessment of compliance of controlled documents with applicable standards and regulations.
- Ensure annual review of controlled documents as prescribed by Suregenex procedures, regulatory agencies and accrediting body.
- Responsible for securing Medical Director approval and annual review for all applicable controlled documents per the established standard operating procedure.
- Actively monitor, in collaboration with regulatory affairs, publications for all standards and regulations to reference to the most current version and is prepared for all pre-announced revisions.
- Responsible for securing applicable contracted business partner approval of revised and new procedures as required.
- Other duties as assigned.
POSITION QUALIFICATIONS
- Accuracy - Ability to perform work accurately and thoroughly.
- Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
- Conflict Resolution - Ability to deal with others in an antagonistic situation.
- Customer Oriented - Ability to take care of the customers needs while following company procedures.
- Detail Oriented - Ability to pay attention to the minute details of a project or task.
- Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.
- Organized - Possessing the trait of being organized or following a systematic method of performing a task.
- Responsible - Ability to be held accountable or answerable for ones conduct.
- Self Confident - The trait of being comfortable in making decisions for oneself.
- Time Management - Ability to utilize the available time to organize and complete work within given deadlines.
- Communication, Oral - Ability to communicate effectively with others using the spoken word.
- Communication - Ability to communicate clearly and concisely.
- Accountability - Ability to accept responsibility and account for his/her actions.
- Adaptability - Ability to adapt to change in the workplace.
- Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
- Compliance Ability of the individual to be in accordance with established guidelines, policy, standards or legislation.
Requirements
- Education: Bachelor's Degree in physical sciences or quality studies is required. Equivalent work experience may be substituted for education.
- Experience: Four to six years document control experience in regulated or certified industry. Knowledge of quality management software preferred.
- Computer Skills: Proficient with Microsoft office suite
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